AI Article Synopsis
- - The study aimed to evaluate the reliability of two ELISA kits (Wantai-IgM and MP-IgM) for detecting IgM antibodies against the hepatitis E virus (HEV) using serum samples from various groups, including healthy individuals and those with suspected or confirmed hepatitis E.
- - Results showed that both kits had similar positive rates, but Wantai-IgM had higher sensitivity and specificity compared to MP-IgM for diagnosing acute hepatitis E, particularly in patients with positive HEV RNA.
- - The conclusion suggests that Wantai-IgM is a more reliable ELISA kit for diagnosing acute hepatitis E due to its superior performance, as it didn't yield false positives from other conditions unlike MP-IgM.
Article Abstract
Objective: To study the reliability of two ELISA kits for detecting IgM antibody against hepatitis E virus (HEV).
Methods: Serum samples from 92 healthy subjects, 71 cases suspected of hepatitis E, 55 patients with confirmed diagnosis of acute hepatitis E, 50 individuals with rheumatoid factor (RF) positive and 54 persons with anti-HAV IgM positive were detected with three hepatitis E diagnostic kits. MP-IgM (MP, Singapore), Wantai-IgM and anti-HEV IgG (Wantai, China). HEV RNA was analyzed with RT-PCR in 52 of 71 cases suspected of hepatitis E.
Results: In healthy subjects,cases suspected of hepatitis E and confirmed acute hepatitis E, the concordance between the two anti-HEV IgM reagents was 73.39% (160/218) and the significant differences in the positive rates of two assays were not observed [46.79% (102/218) vs 44.04% (96/218), chi2 = 0.62, P > 0.05]. Of 71 patients suspected of hepatitis E, the sensitivity for diagnosing acute hepatitis E of Wantai-IgM and MP-IgM were 83.08% (54/65) and 78.46% (51/65) (chi2 = 0.16, P > 0.05), respectively. Among those suspected of hepatitis E with HEV RNA positive, the sensitivity of Wantai-IgM was obviously higher than that of MP-IgM [(97.14%, 34/35) vs (74.29%, 26/35), chi2 = 4.9, P < 0.05]. 48 of 55 patients (87.27%) with confirmed diagnosis of hepatitis E were Wantai-IgM positive while 37 (67.27%) was MP-IgM positive (chi2 = 4.0, P < 0.05). The specificity of Wantai-IgM was higher than MP-IgM [100.00% (202/202) vs 89. 11% (180/202), chi2 = 20.05, P < 0.005]. RF and anti-HAV IgM might cause MP-IgM false positive without interference on Wantai-IgM.
Conclusion: Wantai-IgM should be a good ELISA kit for the diagnosis of acute hepatitis E.
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